Factors affecting continuous participation in follow-up evaluations during a lifestyle intervention programme for type 2 diabetes prevention: The Feel4Diabetes-study.

AIMS: Community- and school-based lifestyle interventions are an efficient method of preventing type 2 diabetes in vulnerable populations. Many participants, however, fail to complete the necessary follow-ups. We investigated factors affecting the continuous participation in follow-up evaluations during the Feel4Diabetes-study, a multilevel intervention programme implemented across Europe. METHODS: Socioeconomic, sociodemographic and clinical factors were assessed for 2702 participants within six participating countries: Bulgaria and Hungary (low-to-middle-income countries, LMIC), Belgium and Finland (high-income countries, HIC) and Greece and Spain (high-income countries under austerity measures, HICAM). RESULTS: Statistically significant differences were detected with respect to sex, control group, education level, employment status, BMI and blood pressure measurements (systolic and diastolic blood pressure). Post hoc analysis revealed significant differences within socioeconomic regions. Higher levels of education were associated with significantly lower attrition in HIC (p < 0.05) and HICAM (p < 0.001), higher employment status was associated with lower attrition in HICAM (p < 0.001) and being female was associated with lower attrition in LMIC (p < 0.001). Surprisingly, the intervention group exhibited higher-than-expected attrition in HIC (p < 0.001) and HICAM (p = 0.003), and lower attrition in LMIC (p = 0.007). When tested together in the same multivariable predictive model, all sociodemographic and socioeconomic variables along with higher BMI retained their statistical significance, while systolic and diastolic blood pressure failed to remain significant. CONCLUSIONS: Key socioeconomic and sociodemographic factors along with BMI play a significant role in determining continuous participation in follow-up evaluations during school- and community-based intervention programmes.

Physical activity in relation to metabolic health and obesity: The Feel4Diabetes study.

AIM: To examine physical activity levels in association with metabolic health and estimate the stability of metabolically healthy obese (MHO) phenotypes over a 2-year period. METHODS: In total, 2848 men and women from families at risk of the development of diabetes were recruited. Participants were classified as obese or non-obese and metabolic health was defined using five existing definitions. Physical activity was estimated with the International Physical Activity Questionnaire and pedometers. RESULTS: Prevalence of the MHO phenotype varied among definitions (0% to 20.2%). Overall, the MHO were more active than the metabolically unhealthy obese (MUO). Daily sitting hours (odds ratio [OR] = 1.055, 95% confidence interval [CI]: 1.009-1.104) and daily steps (per 500; OR = 0.934, 95% CI: 0.896-0.973) were remarkable predictors of metabolic health in individuals with obesity; and likewise, in individuals without obesity. After 2 years, 44.1% of baseline MHO adults transitioned to MUO, while 84.0% of the MUO at baseline remained at the same phenotype. Although physical activity was not a major determinant in phenotype transitioning, daily steps were associated with the maintenance of metabolic health over time in the non-obese group. CONCLUSION: A universally accepted definition for MHO is needed. Being physically active can contribute to a metabolically healthy profile even in the presence of obesity; still, MHO is a transient condition and physical activity alone may not be an adequate factor for its maintenance.

Effectiveness of workplace choice architecture modification for healthy eating and daily physical activity.

BACKGROUND: Modifying the choice architecture of behavioural contexts can facilitate health behaviour change, but existing evidence builds mostly on small-scale interventions limited in duration, targets, strategies, and settings. We evaluated the effectiveness of a one-year hybrid type 2 implementation-effectiveness trial aimed at promoting healthy eating and daily physical activity with subtle modifications to the choice architecture of heterogeneous worksites. The intervention was contextualised to and integrated into the routine operations of each worksite. Effectiveness was evaluated in a quasi-experimental pre-post design. METHODS: Intervention sites (n = 21) implemented a median of two (range 1-9) intervention strategies for healthy eating and one (range 1-5) for physical activity. Questionnaires pre (n = 1126) and post (n = 943) intervention surveyed employees' behavioural patterns at work (food consumption: vegetables/roots, fruit/berries, nuts/almonds/seeds, sweet treats, fast food, water; physical activity: restorative movement, exercise equipment use, stair use). The post-intervention questionnaire also measured employees' perception of and response to three intervention strategies: a packed lunch recipe campaign, a fruit crew-strategy, and movement prompts. Multi- and single-level regression models evaluated effectiveness, treating intervention as a continuous predictor formed of the site-specific dose (n intervention strategies employed) and mean quality (three-point rating per strategy halfway and at the end of the intervention) of implementation relevant to each outcome. RESULTS: Multinomial logistic regression models found the intervention significantly associated with a favourable change in employees' fruit and berry consumption (interaction effect of time and implementation p = 0.006) and with an unfavourable change in sweet treat consumption (p = 0.048). The evidence was strongest for the finding concerning fruit/berry consumption-an outcome that sites with greater dose and quality of implementation targeted by using strategies that reduced the physical effort required to have fruit/berries at work and by covering multiple eating-related contexts at the worksite. The quality of implementation was positively associated with the perception of (p = 0.044) and response to (p = 0.017) the packed lunch recipes, and with response to the fruit crew-strategy (p < 0.001). CONCLUSIONS: The results suggest that a contextualised, multicomponent choice architecture intervention can positively influence eating behaviour in diverse real-world settings over a one-year period, and that higher implementation quality can enhance intervention perception and response. However, outcomes may depend on the type of intervention strategies used and the extent of their delivery.

Registered nurses' perceptions of healthy lifestyle counselling for immigrants in primary healthcare: A focus group study.

BACKGROUND: The use of primary healthcare and health promotion services is low among immigrants compared with native citizens. Immigrants are at risk of developing chronic diseases due to genetics, nutrition and a sedentary lifestyle. Registered nurses play an integral role in teaching, counselling for a healthy lifestyle and care coordination in primary healthcare. AIM: We aimed to explore the perceptions of registered nurses on healthy lifestyle counselling for preventing type 2 diabetes and other chronic diseases among immigrants in the primary healthcare setting. DESIGN: We performed a qualitative descriptive study using focus group interviews. METHODS: Data were collected with semi-structured focus group interviews with a total of 23 registered nurses working in primary healthcare. We recruited the participants by using the purposive sampling method in the primary healthcare setting of four municipalities in Finland. Interviews were audio-recorded, transcribed verbatim and analysed with qualitative inductive content analysis. RESULTS: The participants' perceptions were related to (1) uniform counselling practice for both immigrants and native citizens, (2) challenges in counselling immigrants, (3) understanding cultural factors influencing immigrant counselling, (4) the need to improve immigrant counselling and (5) utilizing insights from practical experience to improve the counselling service. CONCLUSIONS: Developing a culturally sensitive health promotion service is suggested to support the health of immigrants. Moreover, both migrant communities and healthcare professionals should be involved in co-designing and implementing health promotion projects through a community-based participatory approach. IMPACT: Our study contributes to healthcare practice and management by underscoring the need for culturally tailored health promotion services for the at-risk group of immigrants in primary healthcare. Cultural competence in nursing education needs to be reinforced. The provided recommendations inform researchers and policymakers about the health disparities and health needs of immigrants. PUBLIC CONTRIBUTION: Healthcare professionals were consulted in the study design.

Eating behavior dimensions and 9-year weight loss maintenance: a sub-study of the Finnish Diabetes prevention study.

BACKGROUND: Behavioral processes through which lifestyle interventions influence risk factors for type 2 diabetes (T2DM), e.g., body weight, are not well-understood. We examined whether changes in psychological dimensions of eating behavior during the first year of lifestyle intervention would mediate the effects of intervention on body weight during a 9-year period. METHODS: Middle-aged participants (38 men, 60 women) with overweight and impaired glucose tolerance (IGT) were randomized to an intensive, individualized lifestyle intervention group (n = 51) or a control group (n = 47). At baseline and annually thereafter until nine years body weight was measured and the Three Factor Eating Questionnaire assessing cognitive restraint of eating with flexible and rigid components, disinhibition and susceptibility to hunger was completed. This was a sub-study of the Finnish Diabetes Prevention Study, conducted in Kuopio research center. RESULTS: During the first year of the intervention total cognitive (4.6 vs. 1.7 scores; p < 0.001), flexible (1.7 vs. 0.9; p = 0.018) and rigid (1.6 vs. 0.5; p = 0.001) restraint of eating increased, and body weight decreased (-5.2 vs. -1.2 kg; p < 0.001) more in the intervention group compared with the control group. The difference between the groups remained significant up to nine years regarding total (2.6 vs. 0.1 scores; p = 0.002) and rigid restraint (1.0 vs. 0.4; p = 0.004), and weight loss (-3.0 vs. 0.1 kg; p = 0.046). The first-year increases in total, flexible and rigid restraint statistically mediated the impact of intervention on weight loss during the 9-year study period. CONCLUSIONS: Lifestyle intervention with intensive and individually tailored, professional counselling had long-lasting effects on cognitive restraint of eating and body weight in middle-aged participants with overweight and IGT. The mediation analyses suggest that early phase increase in cognitive restraint could have a role in long-term weight loss maintenance. This is important because long-term weight loss maintenance has various health benefits, including reduced risk of T2DM.

Association of adiposity with morbidity in Finnish adults: A register-based follow-up study.

AIMS: The aims of this study were to update risk estimates of obesity related co-morbidities and to provide evidence of the importance of obesity prevention to decision makers. METHODS: The study included 25- to 74-year-old participants (N=22,977) of the National FINRISK Studies in 1997, 2002 and 2007. Body mass index was calculated from measured weight and height at baseline. Data on morbidity were ascertained via linkage to the National Hospital Discharge Register, the Cancer Register and the records of the Social Insurance Institution of Finland until the end of year 2018. The Cox proportional hazards model was used to estimate associations between weight status and the risk of the end-point diseases during follow-up, with adjustment for age and smoking. RESULTS: At baseline, 31% of participants had at least one of the investigated diseases. Overweight, obesity and severe obesity were associated with type 2 diabetes, gout, gallbladder diseases and knee and hip osteoarthritis during the follow-up in both men and women. The risk of coronary heart disease was increased in men who were overweight, obese and severely obese and in women who were obese and severely obese. Risk of asthma was increased only among women who were obese and severely obese. No associations were found between obesity and breast, prostate or colorectal cancer. CONCLUSIONS: The study showed a strong relationship between excess body weight and the prevalence and incidence of several diseases. Obesity prevention is essential to reduce disease burden in the future.

Immigrants' perspectives on healthy life and healthy lifestyle counseling: a focus group study.

BACKGROUND: Immigrants have a higher risk of developing chronic diseases than the general population, but there is a lack of knowledge about appropriate counseling models to promote their health. This study aimed to explore Asian and Russian immigrants' perspectives in Finland on healthy lifestyle and healthy lifestyle counseling to improve the quality of the counseling in primary health care services to prevent type 2 diabetes and other chronic diseases. METHODS: We conducted a qualitative study using semi-structured questions for eight focus groups. The participants were 46 adult immigrants (21 Asian and 25 Russian) living legally in Finland. Interviews were transcribed verbatim, coded, and analyzed using deductive content analysis. RESULTS: We identified three themes regarding healthy lifestyle: (1) limited knowledge on different dimensions of healthy lifestyle, (2) understanding the impact of culture and community on healthy living, and (3) changing the lifestyle to live healthier after immigration. Moreover, we found three themes regarding healthy lifestyle counseling: (1) shortcomings in health care for providing healthy lifestyle counseling, such as lack of educational materials and miscommunication, (2) influential individual factors for using healthy lifestyle counseling, such as stress, and (3) positive outcomes of healthy lifestyle counseling. CONCLUSION: Developing a culturally tailored healthy lifestyle counseling program for the enhancement of immigrants' knowledge regarding healthy lifestyle with consideration of cultural and linguistic aspects is recommended for preventing chronic diseases among immigrants.

Children's food choices are highly dependent on patterns of parenting practices and food availability at home in families at high risk for type 2 diabetes in Europe: Cross-sectional results from the Feel4Diabetes study.

BACKGROUND: Food parenting practices, behaviours and food availability at home are associated with children's food choices; however, these associations have been mainly studied for each parenting practice separately and focused mostly on healthy populations. The aim of the study was to identify patterns of parenting practices (including data regarding food availability at home, food and physical activity-related behaviours and rewards) and to investigate their cross-sectional associations with children's food choices in families at high risk for type 2 diabetes (T2D). METHODS: Data of parents and children (n = 2278), from the Feel4Diabetes study conducted in six European countries, were collected using validated questionnaires. The data analysed included children's food choices, food availability at home and food and physical activity-related parenting practices. Four patterns of parenting practices were identified using principal component analysis, and associations between those components and children's food choices were assessed using adjusted, individual linear regressions. RESULTS: Parenting patterns focusing on unhealthy habits, such as allowing unhealthy snacks and unlimited screen time, providing higher availability of unhealthy foods at home, rewarding with snacks and screen time, were positively associated with children's unhealthy food choices (consumption of savoury/sweet snacks, fizzy drinks, etc.). The parenting patterns providing fruit/vegetables at home, consuming fruit, and being physically active with the child were positively associated with children's healthier food choices (consumption of fruit, vegetables, whole grain cereals, etc.). CONCLUSIONS: Public health initiatives should focus on high-risk families for T2D, assisting them to adopt appropriate parenting practices and behaviours to promote healthier food choices for children.

Self-reported lifestyle behaviours in families with an increased risk for type 2 diabetes across six European countries: a cross-sectional analysis from the Feel4Diabetes-study.

BACKGROUND: A healthy lifestyle decreases the risk of developing type 2 diabetes mellitus. The current cross-sectional study aimed to describe self-reported lifestyle behaviours and compare them to current health guidelines in European Feel4Diabetes-families at risk for developing type 2 diabetes across six countries (Belgium, Finland, Spain, Greece, Hungary and Bulgaria). METHODS: Parents and their children were recruited through primary schools located in low socio-economic status areas. Parents filled out the FINDRISC-questionnaire (eight items questioning age, Body Mass Index, waist circumference, PA, daily consumption of fruit, berries or vegetables, history of antihypertensive drug treatment, history of high blood glucose and family history of diabetes), which was used for the risk assessment of the family. Sociodemographic factors and several lifestyle behaviours (physical activity, sedentary behaviour, water consumption, fruit and vegetable consumption, soft drink consumption, sweets consumption, snack consumption, breakfast consumption) of both adults and children were assessed by parental questionnaires. Multilevel regression analyses were conducted to investigate families' lifestyle behaviours, to compare these levels to health guidelines and to assess potential differences between the countries. Analyses were controlled for age, sex and socio-economic status. RESULTS: Most Feel4Diabetes-families at risk (parents and their children) did not comply with the guidelines regarding healthy behaviours, set by the WHO, European or national authorities. Less than half of parents and children complied with the physical activity guidelines, less than 15% of them complied with the fruit and vegetable guideline, and only 40% of the children met the recommendations of five glasses of water per day. Clear differences in lifestyle behaviours in Feel4Diabetes-families at risk exist between the countries. CONCLUSIONS: Countries are highly recommended to invest in policy initiatives to counter unhealthy lifestyle behaviours in families at risk for type 2 diabetes development, taking into account country-specific needs. For future research it is of great importance to focus on families at risk in order to counter the development of type 2 diabetes and reduce health inequity.

Psychosocial determinants for adherence to a healthy lifestyle and intervention participation in the FINGER trial: an exploratory analysis of a randomised clinical trial.

BACKGROUND AND AIMS: Psychosocial factors may affect adherence to lifestyle interventions and lifestyle changes. The role of psychosocial factors in dementia prevention needs more research. We aimed at clarify the issue in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). METHODS: The population included 1260 participants aged 60-77 years at risk for cognitive decline, randomised to a multidomain lifestyle intervention or regular health advice for 2 years. Adherence was evaluated as participation in the provided activities and actual lifestyle changes, separately for each domain (diet, exercise, social/cognitive activity, vascular risk management) and combined into multidomain. Psychosocial factors were measured at trial baseline (depressive symptoms; study perception; health-related quality of life, HRQoL) and earlier life (hopelessness; satisfaction with family life, achievements, and financial situation). RESULTS: Depressive symptoms, hopelessness, and nonpositive study perception were negatively and HRQoL positively associated with participation in the multidomain intervention. Depressive symptoms, lower HRQoL, hopelessness and dissatisfaction with financial situation were associated with unhealthier lifestyles at baseline. Baseline depressive symptoms and lower HRQoL predicted less improvement in lifestyle, but did not modify the intervention effect on lifestyle change. DISCUSSION AND CONCLUSIONS: Several psychosocial factors were associated with participation in lifestyle intervention, while fewer of them contributed to lifestyle changes. Although the intervention was beneficial for lifestyle changes independent of psychosocial factors, those most in need of lifestyle improvement were less likely to be active. Tailoring lifestyle-modifying strategies based on the need for psychosocial support may add efficacy in future trials. TRIAL REGISTRY: ClinicalTrials.gov NCT01041989 2010-01-05.

Digitally Supported Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Secondary Analysis of Long-Term User Engagement Trajectories in a Randomized Controlled Trial.

BACKGROUND: Digital health interventions may offer a scalable way to prevent type 2 diabetes (T2D) with minimal burden on health care systems by providing early support for healthy behaviors among adults at increased risk for T2D. However, ensuring continued engagement with digital solutions is a challenge impacting the expected effectiveness. OBJECTIVE: We aimed to investigate the longitudinal usage patterns of a digital healthy habit formation intervention, BitHabit, and the associations with changes in T2D risk factors. METHODS: This is a secondary analysis of the StopDia (Stop Diabetes) study, an unblinded parallel 1-year randomized controlled trial evaluating the effectiveness of the BitHabit app alone or together with face-to-face group coaching in comparison with routine care in Finland in 2017-2019 among community-dwelling adults (aged 18 to 74 years) at an increased risk of T2D. We used longitudinal data on usage from 1926 participants randomized to the digital intervention arms. Latent class growth models were applied to identify user engagement trajectories with the app during the study. Predictors for trajectory membership were examined with multinomial logistic regression models. Analysis of covariance was used to investigate the association between trajectories and 12-month changes in T2D risk factors. RESULTS: More than half (1022/1926, 53.1%) of the participants continued to use the app throughout the 12-month intervention. The following 4 user engagement trajectories were identified: terminated usage (904/1926, 46.9%), weekly usage (731/1926, 38.0%), twice weekly usage (208/1926, 10.8%), and daily usage (83/1926, 4.3%). Active app use during the first month, higher net promoter score after the first 1 to 2 months of use, older age, and better quality of diet at baseline increased the odds of belonging to the continued usage trajectories. Compared with other trajectories, daily usage was associated with a higher increase in diet quality and a more pronounced decrease in BMI and waist circumference at 12 months. CONCLUSIONS: Distinct long-term usage trajectories of the BitHabit app were identified, and individual predictors for belonging to different trajectory groups were found. These findings highlight the need for being able to identify individuals likely to disengage from interventions early on, and could be used to inform the development of future adaptive interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6574-y.

The effect of adherence on cognition in a multidomain lifestyle intervention (FINGER).

INTRODUCTION: Lifestyle interventions may prevent cognitive decline, but the sufficient dose of intervention activities and lifestyle changes is unknown. We investigated how intervention adherence affects cognition in the FINGER trial (pre-specified subgroup analyses). METHODS: FINGER is a multicenter randomized controlled trial examining the efficacy of multidomain lifestyle intervention (ClinicalTrials.gov NCT01041989). A total of 1260 participants aged 60 to 77 with increased dementia risk were randomized to a lifestyle intervention and control groups. Percentage of completed intervention sessions, and change in multidomain lifestyle score (self-reported diet; physical, cognitive, and social activity; vascular risk) were examined in relation to change in Neuropsychological Test Battery (NTB) scores. RESULTS: Active participation was associated with better trajectories in NTB total and all cognitive subdomains. Improvement in lifestyle was associated with improvement in NTB total and executive function. DISCUSSION: Multidomain lifestyle changes are beneficial for cognitive functioning, but future interventions should be intensive enough, and supporting adherence is essential.

Occupational complexity and cognition in the FINGER multidomain intervention trial.

INTRODUCTION: Lifetime exposure to occupational complexity is linked to late-life cognition, and may affect benefits of preventive interventions. METHODS: In the 2-year multidomain Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), we investigated, through post hoc analyses (N = 1026), the association of occupational complexity with cognition. Occupational complexity with data, people, and substantive complexity were classified through the Dictionary of Occupational Titles. RESULTS: Higher levels of occupational complexity were associated with better baseline cognition. Measures of occupational complexity had no association with intervention effects on cognition, except for occupational complexity with data, which was associated with the degree of intervention-related gains for executive function. DISCUSSION: In older adults at increased risk for dementia, higher occupational complexity is associated with better cognition. The cognitive benefit of the FINGER intervention did not vary significantly among participants with different levels of occupational complexity. These exploratory findings require further testing in larger studies.

Cost-effectiveness analysis of a school- and community-based intervention to promote a healthy lifestyle and prevent type 2 diabetes in vulnerable families across Europe: the Feel4Diabetes-study.

The Feel4Diabetes-study implemented a school- and community-based intervention to promote healthy lifestyle and prevent type 2 diabetes mellitus (T2DM) in six European countries. The intervention included a special focus on families at increased T2DM risk. The current study evaluates the intervention's cost-effectiveness. A Markov-type health economic model was developed to predict the incidence of T2DM and its complications. Incremental cost-effectiveness ratios (lifetime horizon, societal perspective) were calculated based on the overall intervention effect on health behaviour, and stratified for low- and high-risk families. Sensitivity analyses captured input parameters uncertainty. A budget impact analysis was performed. The increase in children's water consumption and physical activity led to a modest gain in quality adjusted life years (QALYs) at a low intervention cost and budget impact. Medical cost savings due to avoided illness could only be achieved on the very long-term (>30 years). The intervention in its entirety was cost-effective (more QALYs at a reasonable investment) in Belgium, Finland, Bulgaria, and Hungary, while being dominant (net savings and more QALYs) in Greece and Spain. Results were cost-effective for the low-risk families, who only received the school- and community-based intervention component. Results for the high-risk families were only cost-effective (with considerable uncertainty) in Greece and Spain, but not when the intervention would need to be repeated. The Feel4Diabetes-intervention is potentially cost-effective, especially in countries with a high overweight and obesity prevalence, at a limited budget impact. The incremental financial investments to reach and support high-risk families did not result in the hoped-for health benefits.

High need for recovery from work and sleep problems are associated with workers' unhealthy dietary habits.

OBJECTIVE: We aimed to examine the association of recovery from work and sleep with workers' dietary habits. DESIGN: Cross-sectional study. Need for recovery (NFR) from work was assessed with a validated questionnaire. Sleep was assessed with five questions from the Nordic Sleep Questionnaire and sleep quality question. Dietary habits were estimated using a validated sixteen food groups-containing questionnaire. Ordered logistic regression was used to explore the associations of NFR and sleep with dietary habits adjusted for age, education, marital status, work schedule, working full or part time and occupation. SETTING: Follow-up visits of type 2 diabetes prevention study cohort in a Finnish airline company. PARTICIPANTS: The study included 737 men and 605 women. RESULTS: Poor recovery from work was associated with a higher eating frequency (OR = 1·03, 95 % CI 1·00, 1·06), higher intake of fast food (OR = 1·05, 95 % CI 1·02, 1·08) and sweets (OR = 1·05, 95 % CI 1·02, 1·08) as well as lower intake of vegetables (OR = 0·96, 95 % CI 0·93, 0·98) and fruits (OR = 0·96, 95 % CI 0·93, 0·98) among men. In women, poor recovery from work was associated with higher fast food (OR = 1·06, 95 % CI 1·02, 1·09) and desserts consumption (OR = 1·04, 95 % CI 1·00, 1·07). Among men and women, sleep problems were associated with higher eating frequency (men: OR = 1·04, 95 % CI 1·00, 1·07, women: OR = 1·06, 95 % CI 1·02, 1·11), consumption of fast food (men: OR = 1·07, 95 % CI 1·04, 1·11, women: OR = 1·06, 95 % CI 1·02, 1·10) and sweets (men: OR = 1·05, 95 % CI 1·01, 1·08, women: OR = 1·04, 95 % CI 1·00, 1·08). CONCLUSIONS: Poor recovery from work and sleep problems were associated with unfavourable dietary habits especially in men.

Pharmacy-based screening to detect persons at elevated risk of type 2 diabetes: a cost-utility analysis.

BACKGROUND: Early identification of people at elevated risk of type 2 diabetes (T2D) is an important step in preventing or delaying its onset. Pharmacies can serve as a significant channel to reach these people. This study aimed to assess the potential health economic impact of screening and recruitment services in pharmacies in referring people to preventive interventions. METHODS: A decision analytic model was constructed to perform a cost-utility analysis of the expected national health economic consequences (in terms of costs and quality-adjusted life years, QALYs) of a hypothetical pharmacy-based service where people screened and recruited through pharmacies would participate in a digital lifestyle program. Cost-effectiveness was considered in terms of net monetary benefit (NMB). In addition, social return on investment (SROI) was calculated as the ratio of the intervention and recruitment costs and the net present value of expected savings. Payback time was the time taken to reach the break-even point in savings. In the base scenario, a 20-year time horizon was applied. Probabilistic and deterministic sensitivity analyses were applied to study robustness of the results. RESULTS: In the base scenario, the expected savings from the pharmacy-based screening and recruitment among the reached target cohort were 255.3 m€ (95% CI - 185.2 m€ to 717.2 m€) in pharmacy visiting population meaning 1412€ (95% CI - 1024€ to 3967€) expected savings per person. Additionally, 7032 QALYs (95% CI - 1344 to 16,143) were gained on the population level. The intervention had an NMB of 3358€ (95% CI - 1397€ to 8431€) using a cost-effectiveness threshold of 50,000 €/QALY. The initial costs were 122.2 m€ with an SROI of 2.09€ (95% CI - 1.52€ to 5.88€). The expected payback time was 10 and 8 years for women and men, respectively. Results were most sensitive for changes in effectiveness of the intervention and selected discount rate. CONCLUSIONS: T2D screening and recruitment to prevention programs conducted via pharmacies was a dominant option providing both cost savings and QALY gains. The highest savings can be potentially reached by targeting recruitment at men at elevated risk of T2D.

Feel4Diabetes healthy diet score: development and evaluation of clinical validity.

BACKGROUND: The aim of this paper is to present the development of the Feel4Diabetes Healthy Diet Score and to evaluate its clinical validity. METHODS: Study population consisted of 3268 adults (63% women) from high diabetes risk families living in 6 European countries. Participants filled in questionnaires at baseline and after 1 year, reflecting the dietary goals of the Feel4Diabetes intervention. Based on these questions the Healthy Diet Score was constructed, consisting of the following components: breakfast, vegetables, fruit and berries, sugary drinks, whole-grain cereals, nuts and seeds, low-fat dairy products, oils and fats, red meat, sweet snacks, salty snacks, and family meals. Maximum score for each component was set based on its estimated relative importance regarding T2DM risk, higher score indicating better quality of diet. Clinical measurements included height, weight, waist circumference, heart rate, blood pressure, and fasting blood sampling, with analyses of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Analysis of (co) variance was used to compare the Healthy Diet Score and its components between countries and sexes using baseline data, and to test differences in clinical characteristics between score categories, adjusted for age, sex and country. Pearson's correlations were used to study the association between changes from baseline to year 1 in the Healthy Diet Score and clinical markers. To estimate reproducibility, Pearson's correlations were studied between baseline and 1 year score, within the control group only. RESULTS: The mean total score was 52.8 ± 12.8 among women and 46.6 ± 12.8 among men (p <  0.001). The total score and its components differed between countries. The change in the Healthy Diet Score was significantly correlated with changes in BMI, waist circumference, and total and LDL cholesterol. The Healthy Diet Score as well as its components at baseline were significantly correlated with the values at year 1, in the control group participants. CONCLUSION: The Feel4Diabetes Healthy Diet Score is a reproducible method to capture the dietary information collected with the Feel4Diabetes questionnaire and measure the level of and changes in the adherence to the dietary goals of the intervention. It gives a simple parameter that associates with clinical risk factors in a meaningful manner. TRIAL REGISTRATION: Clinicaltrials.gov NCT02393872. Registered March 20, 2015.

Two-stage, school and community-based population screening successfully identifies individuals and families at high-risk for type 2 diabetes: the Feel4Diabetes-study.

BACKGROUND: The implementation of population screening and early prevention strategies targeting individuals at high-risk for type 2 diabetes (T2D) seems to be a public health priority. The current work aimed to describe the screening procedure applied in the Feel4Diabetes-study and examine its effectiveness in identifying individuals and families at high risk, primarily for T2D and secondarily for hypertension, among vulnerable populations in low to middle-income countries (LMICs) and high-income countries (HICs) across Europe. METHODS: A two-stage screening procedure, using primary schools as the entry-point to the community, was applied in low socioeconomic status (SES) regions in LMICs (Bulgaria-Hungary), HICs (Belgium-Finland) and HICs under austerity measures (Greece-Spain). During the first-stage screening via the school-setting, a total of 20,501 parents (mothers and/or fathers) of schoolchildren from 11,396 families completed the Finnish Diabetes Risk Score (FINDRISC) questionnaire, while their children underwent anthropometric measurements in the school setting. Parents from the identified "high-risk families" (n = 4484) were invited to participate in the second-stage screening, including the measurement of fasting plasma glucose (FPG) and blood pressure (BP). In total, 3153 parents participated in the second-stage screening (mean age 41.1 ± 5.6 years, 65.8% females). RESULTS: Among parents who attended the second-stage screening, the prevalence of prediabetes (as defined by impaired fasting glucose; FPG 100-125 mg/dl) and T2D (FPG > 126 mg/dl) was 23.2 and 3.0% respectively, and it was found to be higher in the higher FINDRISC categories. The percentage of undiagnosed T2D among the participants identified with T2D was 53.5%. The prevalence of high normal BP (systolic BP 130-139 mmHg and/ or diastolic BP 85-89 mmHg) and hypertension (systolic BP ≥ 140 mmHg and/ or diastolic BP ≥ 90 mmHg) was 14 and 18.6% respectively, which was also higher in the higher FINDRISC categories. The percentage of cases not receiving antihypertensive treatment among the participants identified with hypertension was 80.3%. CONCLUSION: The findings of the current study indicate that the two-stage school and community-based screening procedure followed, effectively identified high-risk individuals and families in vulnerable populations across Europe. This approach could be potentially scalable and sustainable and support initiatives for the early prevention of T2D and hypertension. TRIAL REGISTRATION: The Feel4Diabetes-intervention is registered at https://clinicaltrials.gov/ (NCT02393872; date of trial registration: March 20, 2015).

Obtaining evidence base for the development of Feel4Diabetes intervention to prevent type 2 diabetes - a narrative literature review.

BACKGROUND: Feel4Diabetes was a school and community based intervention aiming to promote healthy lifestyle and tackle obesity for the prevention of type 2 diabetes among families in 6 European countries. We conducted this literature review in order to guide the development of evidence-based implementation of the Feel4Diabetes intervention. We focused on type 2 diabetes prevention strategies, including all the phases from risk identification to implementation and maintenance. Special focus was given to prevention among vulnerable groups and people under 45 years. METHODS: Scientific and grey literature published between January 2000 and January 2015 was searched for relevant studies using electronic databases. To present the literature review findings in a systematic way, we used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. A complementary literature search from February 2015 to December 2018 was also conducted. RESULTS: The initial review included 27 studies with a follow-up ≥12 months and 9 studies with a follow-up ≥6 months and with a participant mean age < 45 years. We found out that interventions should be targeted at people at risk to improve recruiting and intervention effectiveness. Screening questionnaires (primarily Finnish Diabetes Risk Score FINDRISC) and blood glucose measurement can both be used for screening; the method does not appear to affect intervention effectiveness. Screening and recruitment is time-consuming, especially when targeting lower socioeconomic status and age under 45 years. The intervention intensity is more important for effectiveness than the mode of delivery. Moderate changes in several lifestyle habits lead to good intervention results. A minimum of 3-year follow-up seemed to be required to show a reduction in diabetes risk in high-risk individuals. In participants < 45 years, the achieved results in outcomes were less pronounced. The complementary review included 12 studies, with similar results regarding intervention targets and delivery modes, as well as clinical significance. CONCLUSION: This narrative review highlighted several important aspects that subsequently guided the development of the Feel4Diabetes high-risk intervention. Research on diabetes prevention interventions targeted at younger adults or vulnerable population groups is still relatively scarce. Feel4Diabetes is a good example of a project aiming to fill this research gap. TRIAL REGISTRATION: clinicaltrials.gov NCT02393872, registered 20th March 2015.

Do physical activity and screen time mediate the association between European fathers' and their children's weight status? Cross-sectional data from the Feel4Diabetes-study.

BACKGROUND: Most research on parenting and childhood obesity and obesity-related behaviours has focused on mothers while fathers have been underrepresented. Yet, recent literature has suggested that fathers uniquely influence their children's lifestyle behaviours, and hence could also affect their weight status, but this has not yet been scientifically proven. Therefore, the present study aimed to determine whether the association between fathers' weight status and their children's weight status is mediated by fathers' and children's movement behaviours (i.e. physical activity (PA) and screen time (ST)). METHODS: Cross-sectional data of 899 European fathers and their children were analyzed. Fathers/male caregivers (mean age = 43.79 ± 5.92 years, mean BMI = 27.08 ± 3.95) completed a questionnaire assessing their own and their children's (mean age = 8.19 ± 0.99 years, 50.90% boys, mean BMIzscore = 0.44 ± 1.07) movement behaviours. Body Mass Index (BMI, in kg/m2) was calculated based on self-reported (fathers) and objectively measured (children) height and weight. For children, BMI z-scores (SD scores) were calculated to obtain an optimal measure for their weight status. Serial mediation analyses were performed using IBM SPSS 25.0 Statistics for Windows to test whether the association between fathers' BMI and children's BMI is mediated by fathers' PA and children's PA (model 1) and fathers' ST and children's ST (model 2), respectively. RESULTS: The present study showed a (partial) mediation effect of fathers' PA and children's PA (but not father's ST and children's ST) on the association between fathers' BMI and children's BMI (model for PA; coefficient: 0.001, 95% CI: [0.0001, 0.002]; model for ST; coefficient: 0.001, 95% CI: [0.000, 0.002]). Furthermore, fathers' movement behaviours (PA and ST) were positively associated with their children's movement behaviours (PA and ST) (model for PA, coefficient: 0.281, SE: 0.023, p < 0.001; model for ST, coefficient: 0.345, SE: 0.025, p < 0.001). CONCLUSIONS: These findings indicate that the influence of fathers on their children's weight status partially occurs through the association between fathers' PA and children's PA (but not their ST). As such, intervening by focusing on PA of fathers but preferably of both members of the father-child dyad (e.g. engaging fathers and their children in co-PA) might be a novel and potentially effective strategy for interventions aiming to prevent childhood overweight and obesity. Longitudinal studies or intervention studies confirming these findings are however warranted to make meaningful recommendations for health intervention and policy. TRIAL REGISTRATION: The Feel4Diabetes-study is registered with the clinical trials registry http://clinicaltrials.gov , ID: 643708 .